ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

Part of paid clinical trials in Carlsbad, California.

Sponsor
argenx
Study ID
NCT07284420
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • AChR-Ab Seropositive Generalized Myasthenia Gravis
  • Generalized Myasthenia Gravis
  • Generalized Myasthenia Gravis (gMG)
  • MG
  • Myasthenia Gravis
  • gMG

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod IV — BIOLOGICAL
    Intravenous infusion of efgartigimod
  • Empasiprubart IV — BIOLOGICAL
    Intravenous infusion of empasiprubart

Study Details

This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life. The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis. The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170

Key Dates

Start date
Dec 19, 2025
Status verified
Feb 2026
Primary completion
Mar 7, 2028
Completion
Mar 7, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod IV + Empasiprubart IV
    Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B
  • Experimental: Efgartigimod IV (part A + C)
    Participants not eligible for part B, receiving efgartigimod IV in part A and C

Primary Outcome Measure

Incidence of adverse events and serious adverse events in parts A and B [ Time Frame: Up to 21 weeks ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Profound Research LLC - CarlsbadCarlsbadCalifornia92011
Gregory Sahagian, MD
[email protected]
760-732-0557
Visionary Investigators NetworkMiamiFlorida33176
Andrew Lerman, MD
[email protected]
786-655-8010
University of South FloridaTampaFlorida33620
Tuan Vu, MD
[email protected]
813-974-9413
Dent Neurologic Institute - AmherstAmherstNew York14226
Luisa Rojas Estupinan, MD
[email protected]
716-250-2000
Ohio State Martha Morehouse Outpatient CareColumbusOhio43221-3502
Miriam Freimer, MD
[email protected]
614-293-4969
Erlanger Health SystemChattanoogaTennessee37403
Joshua Alpers, MD
[email protected]
423-778-3900
National Neuromuscular Research InstituteAustinTexas78756
Yessar Hussain, MD
[email protected]
512-920-0140
University of Texas- San Antonio - Health Science Center - PPDSSan AntonioTexas78229
Ratna Bhavaraju-Sanka, MD
[email protected]
210-567-8229

Find similar trials in Carlsbad, CA

By research site
Profound Research LLC - Carlsbad· Carlsbad, CAVisionary Investigators Network· Miami, FLUniversity of South Florida· Tampa, FLDent Neurologic Institute - Amherst· Amherst, NYOhio State Martha Morehouse Outpatient Care· Columbus, OHErlanger Health System· Chattanooga, TN

Related Studies